3. The DEPARTMENT OF HEALTH as:
Lead agency for Health and Healthcare
Services:
As mandated by law to protect, promote and
maintain the health of the Filipinos
As an influential leader of the health sector
As it continues to provide
guidelines, policies, standards and state of the art
in health and healthcare
4. What is Regulation?
• A process or activity in which government
requires or prescribes certain activities or
behavior on the part of individuals and
institutions through a continuing
administrative process.
• A prescription by the government that
must be complied with by the intended
individuals and firms.
- Howlett and Ramesh
5. What is Regulation?
• The use of the coercive power of the state to
change the behavior of or to impose constraints
on organization and individuals.
• Includes the full range of legal instruments
(laws, decrees, orders, codes, administrative
rules, guidelines), whether issued by the
government or by non-governmental bodies to
which the government has delegated regulatory
power
- Roberts et.al
7. Regulatory Approaches in the
Health Sector
• Regulating capacity
• Regulating prices
• Regulating quality
• Regulating market structure and levels of
service
• Regulating entitlements
9. GENERAL FUNCTIONS
1. Sets standards and guidelines for regulation of various health
facilities and services
2. Disseminates regulatory policies and standards for information
and compliance
3. Issues permits to construct, license to operate, certificates of
accreditation, SEC endorsement as to name of health
facility, certification of BHFS regulated health facilities for foreign
travel purposes (DFA requirement), authentication of PEME
certificates for OCWs and clearance to operate HMO’s
4. Ensures sustainability of health facilities compliance with
regulatory standards through monitoring and quality assurance
4. Provides consultation and advisory services to stakeholders
5. Develops and conducts research relative to the regulation of
health facilities and services
15. FACILITIES MANDATE REGULATORY
INSTRUMENT
1. Ambulatory Surgical
Clinic
• AO 183 s 2004
(amendment in
progress)
• AO 24 s. 1994
• AO 2008-0027
• AO 2008-0111
License to Operate
2. Dialysis Clinic • AO 2013-0003
• AO 2012-0001
• AO 2008-0027
• AO 2006-0037
• AO 163 s. 2004
License to Operate
3. Drug Abuse Treatment
and Rehabilitation
Center
• RA 9165
• DDB Resolution (IRR
Governing Accreditation
of Drug Treatment and
Rehabilitation Centers
and Accreditation of
Center Personnel)
Certificate of Accreditation
BASIS FOR REGULATION
16. FACILITIES MANDATE REGULATORY
INSTRUMENT
4. Drug Testing Laboratory • RA 9165
• DDB Resolution (IRR
Governing Accreditation
of DTLs in the Philippines,
as revised)
Certificate of Accreditation
5. Health Maintenance
Organization
6. Kidney Transplant Facility
7. Medical Facility for
Overseas Workers and
Seafarers
• AO 34 s. 1994
• AO 2008-0034
• AO 81 s. 2003
• RA 10022
• AO 2013-0006
• AO 2010-0022
• AO 2008-0027
• AO 2007-0025
• AO 181 s. 2004
Clearance to Operate
Certificate of Accreditation
Certificate of Accreditation
BASIS FOR REGULATION
17. BASIS FOR REGULATION
FACILITIES MANDATE REGULATORY
INSTRUMENT
8. Newborn Screening
Center
• RA 9288 and its IRR
• AO 2008-0026-A
• AO 2008-0026
• DM 2008-0123
• DM2008-0044
• DM 2008-0020
• AO 2008-0002
• AO 2007-0001
Certificate of Accreditation
9. Water Testing
Laboratory
10. Dental Laboratory
• PD 856
• AO 2006-0024
• PD 1542 s. 1978
• DC 79 s. 1988
• AO 28 s 2003
• RA 9484 s. 2007
• AO 2008-0010
• AO 2008-0019
Certificate of Accreditation
License to Operate
18. FACILITIES MANDATE REGULATORY
INSTRUMENT
11, 12 and 13. Blood
Service Facility, Blood
Bank and BC
• RA 7719
• AO 2005-0002
• AO 2008-0008
License to Operate
14. Clinical Laboratory • RA s. 4688
• AO 2007-0027 and 2007A
• AO 2008-0007
• AO 2008-0002
• DM 2009-0086
• DM 2009-0183
License to Operate
15. Drinking Water Testing
Laboratory
• PD 856
• RA 9275
• AO 2006-0024
• AO 2007-0001
• DC 2007-0134
• AO 2008-0002
Certificate of Accreditation
BASIS FOR REGULATION
19. FACILITIES MANDATE REGULATORY
INSTRUMENT
16. HIV Testing Laboratory • AO 2005-0027
• AO 2005-0027-A
• AO 2008-0002
Subsumed in the LTO of CL
and BB
17. Hospital • RA s. 4226
• AO 2012-0012
• AO 2011-0020
• AO 2010-0081
• AO 2008-0021
• AO 2007- 0021
• AO 2007-0022
License to Operate
18. Dental Clinic
a. Occupational
b. Private School
• AO 3 s 1998
• AO 4 s 1998
Certificate of Accreditation
19. Psychiatric Care Facility • RA 4226
• AO 147 s. 2004
• AO 2005-0029
License to Operate
BASIS FOR REGULATION
20. 20 and 21. Birthing Home
and Other HFs
Category A without
beds (e.g. RHUs)
• RA s. 4226
• AO 2012-0012
• AO 2011-0020
License to Operate
BASIS FOR REGULATION
FACILITIES MANDATE REGULATORY
INSTRUMENT
21. Only those with money (i.e., the rich) can fully
pay for out of pocket payments and often they
have generous health insurance
The near-poor and the lower middle classes can
become impoverished to meet out of pocket
payments for health care.
The very poor don’t even have pockets
23. Administrative Order
No. 2012 – 0012
“New Classification of Hospitals and Other
Health Facilities”
Administrative Order
No. 2011 – 0020
“Streamlining of Licensure and Accreditation
of Hospitals”
24. Administrative Order
No. 2011 – 0020
“Streamlining of Licensure and
Accreditation of Hospitals”
Department of Health
Bureau of Health Facilities and Services
25. OBJECTIVE
To improve access to quality
health facilities with the
efficient use of limited
government resources and
without compromising the
quality of care
26. Scope and Coverage
Regulatory offices – BHFS,
FDA, CHD, PhilHealth
All government and private
hospitals
27. DOH LICENSE
1. All DOH licensed hospitals shall be
deemed automatically accredited by
PhilHealth as Centers of Safety.
(Basic Participation per Philhealth
Circular No. 54)
2. Stakeholders shall comply with the
standards and requirements
prescribed in the enhanced
assessment tool for licensure of
hospitals posted at DOH website.
28. Administrative Order
No. 2012 – 0012
“New Classification of Hospitals and
Other Health Facilities”
Department of Health
Bureau of Health Facilities and Services
29. EVOLUTION OF HOSPITAL NOMENCLATURE
AO No. 68–A
s. 1989
AO No. 70–A
s. 2002
AO No. 147
s. 2004
AO No.
2005 – 0029
Primary Infirmary Infirmary Level 1
Secondary
First Level
Referral Hospital
Primary Care
Hospital
Level 2
Tertiary
(Non-Teaching)
Second Level
Referral Hospital
Secondary
Care Hospital
Level 3
Tertiary
(Teaching)
Third Level
Referral Hospital
Tertiary Care
Hospital
Level 4
30. Legal Basis for Defining a Hospital Per
R.A. 4226
Section 2 Section 8 Section 16
Beds or
cribs or
bassinets
for 24 hour
use or
longer
Bed space
Laboratory
OR
X-ray
Pharmacy
OPD
DR
Isolation
Morgue
Classify hospitals
as to:
General or Special
Service Capacity
Size or bed capacity
Training or not
All 3 Sections of the Law have to be complied
with to be classified as a hospital.
31. OLD CLASSIFICATION OF HOSPITALS
PER DOH A.O. NO. 2005 – 0029
LEVEL 1 LEVEL 2 LEVEL 3 LEVEL 4
Primary care Level 1 plus: Level 2 plus: Level 3 plus:
General Medicine Surgery Specialty Clinical
Care with
departmentalized
clinical services
Teaching and/or training
with at least 1 accredited
residency training
program for physicians
General
Pediatrics
AnesthesiaEmergency and
Out-patient
Services
General Dentistry
Department of
Emergency Medicine
General
Obstetrics
Pharmacy Provision for ICU
Specialized and sub-
specialized forms of
treatment, surgical
procedure and intensive
care
Non-surgical
Gynecology
Secondary
Clinical
Laboratory
Tertiary Clinical
Laboratory
Rehabilitation Service
Minor Surgery
1st Level
Radiology
2nd Level
Radiology
3rd Level Radiology
32. INCONSISTENCY OF OLD CLASSIFICATION VS. LAW
CATEGORY
Bed
space
OR DR OPD Lab X-ray P I M
Consistent
with Law
Level 1 ✓ X ✓ X X X X X X NO
Level 2 ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ YES
Level 3
✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
YES
Level 4
✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
YES
Therefore, Level 1 does not qualify as a hospital and must be given
a different category for licensure purposes.
33. Classification of Hospitals
According to Ownership:
A. Government
Created by law. May be under DOH, DND,
DOJ, PNP, LGU, SUCs, GOCC and others
B. Private
May be a single proprietorship, partnership,
corporation, cooperative, foundation,
religious, non-government organization and
others
A.O. No. 2012 – 0012 Rule V. B. 1. a., p. 6
34. Classification of Hospitals
According to Functional Capacity:
A. General Hospital
Provides medical and surgical care to the sick and
injured and maternity care and shall have as
minimum, the following clinical services: medicine,
pediatrics, obstetrics and gynecology, surgery and
anesthesia, emergency services, out-patient and
ancillary services.
B. Specialty Hospital
Specializes in a particular disease or condition or in
one type of patient.
A.O. No. 2012 – 0012 Rule V. B. 1. b., p.
6
35. Examples of SPECIALTY HOSPITALS
Particular
Disease
Particular
Organ(s)
Particular Group
of Patients
National
Orthopedic
Hospital
Lung Center
Philippine Children’s
Medical Center
National Center
for Mental Health
Philippine Heart
Center
National Children’s
Hospital
San Lazaro
Hospital
National Kidney
and Transplant
Institute
Dr. Jose Fabella
Memorial Hospital
36. Classification of Hospitals
According to Trauma Capability:
Guidelines formulated by PCS
A. Trauma-Capable Facility
A DOH licensed hospital designated as a trauma
center.
B. Trauma-Receiving Facility
A DOH licensed hospital within the trauma service
area which receives trauma patients for transport
to the point of care or a trauma center.
A.O. No. 2012 – 0012 Rule V. B. 1. c. 3., p.
8
37. OLD NEW
LEVEL I
RE-CLASSIFY TO
OTHER HEALTH
FACILITIES
LEVEL 2 LEVEL 1
LEVEL 3 LEVEL 2
LEVEL 4 LEVEL 3
Classification of General
Hospitals
38. GENERAL LEVEL 1 LEVEL 2 LEVEL 3
Clinical
Services
and
Facilities for
In-Patients
Consulting
Specialists in:
Medicine
Pediatrics
OB-GYNE
Surgery
Level 1 plus all: Level 2 plus all:
Departmentalized
Clinical Services
Teaching/ training with
accredited residency
training program in
the 4 major clinical
services
Emergency and Out-
patient Services
Respiratory Unit Physical Medicine and
Rehabilitation Unit
Isolation Facilities General ICU
Surgical/ Maternity
Facilities
High Risk
Pregnancy Unit
Ambulatory Surgical
Clinic
Dental Clinic NICU Dialysis Clinic
Ancillary
Services
Secondary Clinical
Laboratory
Tertiary Clinical
Laboratory
Tertiary lab with
histopathology
Blood Station Blood Station Blood Bank
1st Level X-ray
2nd Level X-ray
with mobile unit
3rd Level X-ray
Pharmacy
39. NEW CLASSIFICATION OF OTHER HEALTH FACILITIES
A B C D
Primary Care
Facility
Custodial Care
Facility
Diagnostic/
Therapeutic Facility
Specialized Out-
Patient Facility
With In-patient
Beds:
Infirmary/
Dispensary
Birthing Home
Psychiatric
Care Facility
Laboratories:
Clinical Lab/ HIV
Blood Service
Facilities
Drug Test Lab
NB Screening Lab
Water Lab
Dialysis Clinic
(DC)
Ambulatory
Surgical Clinic
(ASC)
Without Beds:
Medical Out-
patient Clinics
OFW Clinics
Dental Clinics
Drug Abuse
Treatment and
Rehabilitation
Center
(DATRC)
Ionizing Machines as
X-ray, CT scan,
mammography and
others
In-Vitro
Fertilization (IVF)
Centers
Sanitarium/
Leprosarium
Non-Ionizing Machines
as ultrasound, MRI and
others
Radiation
Oncology Facility
Nursing Home Nuclear Medicine
Oncology Center/
Clinic
40. HOSPITALS
OTHER HEALTH
FACILITIES
GENERAL
Level 1
Level 2
Level 3
(Teaching/
Training)
A. Primary Care Facility
B. Custodial Care
Facility
C. Diagnostic/
Therapeutic Facility
SPECIALTY
D. Specialized Out-
Patient Facility
NEW CLASSIFICATION
41. Implementing Mechanisms
The name of the institution shall be
compatible with the functional capacity
of the health facility. All health facilities
regulated by DOH applying for SEC
and/or DTI registration shall undergo
clearance from BHFS.
Example: A clinic cannot be called a
medical center.
A.O. No. 2012 – 0012 Rule V. A. 6 p. 5
42. Implementing Mechanisms
Every health facility shall
have a duly licensed
physician to oversee the
clinical/ medical operations
of the health facility.
A.O. No. 2012 – 0012 Rule V. B. 3. a. p. 11
43. Implementing Mechanisms
Applications for DOH-PTC of New
Hospitals having at least 100 beds
shall require the approval of the
Secretary of Health. The foregoing is
not limited to New Hospitals but covers
other health facilities as may be
required by the Secretary of Health.
A.O. No. 2012 – 0012 Rule VI. B. 6 p. 15
44. INITIAL LTO
Each CHD shall issue the
initial LTO of other health
facilities under Category A –
Primary Care Facility with
in-patient beds.
A.O. No. 2012 – 0012 Rule VI. C. 3. p. 15
45. INITIAL LTO
BHFS shall issue LTO of all
new hospitals and other
health facilities covered by
other DOH issuances.
A.O. No. 2012 – 0012 Rule VI. C. 3. p. 15
46. RENEWAL OF LTO
Each CHD shall renew LTO of
Level 1 hospitals and renew
LTO of other health facilities
under Category A – Primary
Care Facility with in-patient
beds.
A.O. No. 2012 – 0012 Rule VI. D. 1. p. 16
47. RENEWAL OF LTO
BHFS shall renew LTO of Level 2
and Level 3 hospitals following
OSS licensure system for hospitals
and renew LTO/accreditation of
health facilities covered by other
DOH issuances.
A.O. No. 2012 – 0012 Rule VI. D. 2. p. 16
48. TRANSITORY PROVISIONS
1. These rules and regulations shall be
enforced on New Hospitals applying for
LTO.
2. Hospitals categorized as Level 2, 3, 4,
applying for renewal of LTO shall be
given a grace period of 3 years to attain
full compliance with these rules and
regulations.
A.O. No. 2012 – 0012 Rule XIII. p. 18
49. 3. Existing Level 1 health facilities
which cannot comply with the
provisions stated in Sections 2, 8
and 16 of R.A. 4226, shall be re-
classified to ‘Other Health Facilities’.
A.O. No. 2012 – 0012 Rule XIII. p. 18
50. CERTIFICATE OF NEED
SPECIFIC GUIDELINES
The requirement for a Certificate of Need (CON)
shall only apply to proposed new government
general hospitals.
Private individuals or corporations who shall
establish new general hospitals shall no longer be
required to secure a Certificate of Need (CON)
from the Center for Health Development.
Proposed new private general hospitals should
have at least one hundred (100) beds.
53. “In matters of health, I believe our world is
out of balance, possibly as never before in history.
We have never had such a sophisticated arsenal
of technologies for treating disease and
prolonging life. Yet the gaps in health outcomes
keep getting wider.”
Dr. Margaret Chan
WHO Director General
54. HealthcareSystem
Promotive &
Preventive Care
Primary Care
Secondary Care
Tertiary Care
Restorative Care
Continuing Care
Prevention
Early Detection &
Routine Care
Emergency Treatment
Education
Critical Care
Specialized Care
Intermediate & Follow-Up Care
Rehabilitation
Home Care
Long Term & Chronic Care
Personal Care
Hospice Care
Bgy. Health Stations, Rural
Health Units/ Health Centers,
Clinics, Dispensaries
Infirmaries (Level 1 Category
Hospitals), Community,
Municipal & District
Hospitals, Birthing Homes,
Ambulatory Surgical Clinics
City, Provincial, Level 1
Category Hospitals
National, Regional, Level 2
and 3 Category Hospital,
Medical Centers, Teaching/
Training Hospitals
National, Regional, Level 2
and 3 Category Hospital,
Medical Centers, Teaching/
Training Hospitals, Rehab
Facilities
Hospice Care, Custodial &
Chronic Care Facilities,
Retirement, Institutional
Care Facilities
LEVEL OF CARE DESCRIPTION FACILITIES AND SERVICES
55. Role of Government
For the health sector and given the economic crisis
provides the government the rare opportunity to push
the needed reforms that would lead to universal health
care for Filipinos.
With the national and local elections, there will be a
new set of leaders at the national and local levels. The
government may rewrite the rules on health care
provision in the country, consistent with the
constitutional provision that asserts that health is a
right of every Filipino citizen.
55
56. Health at the centre of development
Health is a right.
Access to health care is a fundamental entitlement.
Investing in health is investing in human capital.
Human capital is the foundation of economic
productivity.
Health is a core concern of development.
59. Challenges in Health System Performance
Access --- 1.3 Billion individuals with no access to health
care worldwide
Scale --- safe, proven and reasonable interventions not
reaching those in need
Distribution --- those with unmet needs are disproportionate
to those with lesser means
Protection/Safety --- too many are worse off through
encounters with the health system
Systems capabilities --- conventional frameworks and
responses to dealing with complex challenges
Dissatisfied patients --- disease rather than customer driven
services, limited patient voice in treatment decisions
